BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1073685 · Received July 3, 2008

    Report

    Report Number
    1423500-2008-00597
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    April 8, 2008
    Report Date
    June 10, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE EVALUATION DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS OVERFILL DISCOVERED DURING EVALUATION. BASED ON A REVIEW OF ALL AVAILABLE THERAPY LOG DATA, THE MOST PROBABLE CAUSE OF THE OVERFILL WAS DETERMINED TO BE INSUFFICIENT DRAIN WHEN MULTIPLE CYCLES ADVANCED TO FILL WHEN SLOW / NO FLOW CONDITION OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. IT WAS NOTED IN THE THERAPY LOG THAT THE PATIENT HAD BEEN DRAINING LESS THAN THE FILL VOLUME IN PREVIOUS CYCLES OF THIS THERAPY SESSION, WHICH COULD HAVE CONTRIBUTED TO THE INCREASED DRAIN VOLUME IN DRAIN 5. THE DEVICE WILL BE ROUTED TO THE SERVICE AREA.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, A POSSIBLE OVERFILL SITUATION WAS IDENTIFIED WHICH OCCURRED IN 2008 DURING DRAIN CYCLE 5. THE PATIENT'S ULTRAFILTRATION READING WAS 837MLS INDICATING THE HOME PATIENT (HP) DRAINED 837MLS MORE THAN THEIR PROGRAMMED FILL VOLUME OF 2400MLS. THIS INFORMATION GIVES A TOTAL DRAIN VOLUME OF 3237 MLS (837MLS + 2400MLS). FOLLOW UP WITH THE DIALYSIS CENTER NURSE ON THREE MONTHS LATER, REVEALED THE HP WAS BEDRIDDEN AND NOT ABLE TO SIT UP OR MOVE AROUND WITHOUT ASSISTANCE FROM HIS CAREGIVER. AS A RESULT, WHEN THE HP WAS NOT IN A POSITION FAVORABLE TO DRAIN WELL, HE COULD NOT JUST MOVE AROUND ON HIS OWN TO DRAIN BETTER. THE RN RELATED THAT THE HP EXPERIENCED SHORTNESS OF BREATH AND WAS MILDLY UNCOMFORTABLE AROUND THE TIME OF THE INCIDENT, WHICH SHE ATTRIBUTES TO THE HP'S OWN INTOLERANCE TO THE PROGRAMMED FILL VOLUME OF 2400MLS. THE RN INDICATES THAT THIS WAS AN ONGOING DIFFICULTY FOR THE HP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1